United States v. ARTICLE OF DRUG, ETC., No. 15519.

CourtUnited States Courts of Appeals. United States Court of Appeals (3rd Circuit)
Writing for the CourtHASTIE and SMITH, Circuit , and KIRKPATRICK
Citation362 F.2d 923
Decision Date11 July 1966
Docket NumberNo. 15519.
PartiesUNITED STATES of America v. ARTICLE OF DRUG consisting of undetermined quantities of vitamin, mineral, and other dietary preparations DESIGNATED as follows: B-COMPLEX CHOLINOS CAPSULES, etc. Foods Plus, Inc., (Claimant), Appellant.

362 F.2d 923 (1966)

UNITED STATES of America
v.
ARTICLE OF DRUG consisting of undetermined quantities of vitamin, mineral, and other dietary preparations DESIGNATED as follows: B-COMPLEX CHOLINOS CAPSULES, etc.
Foods Plus, Inc., (Claimant), Appellant.

No. 15519.

United States Court of Appeals Third Circuit.

Argued February 23, 1966.

Decided July 11, 1966.


362 F.2d 924
COPYRIGHT MATERIAL OMITTED
362 F.2d 925
Milton A. Bass, New York City (Bass & Friend, New York City, on the brief), for appellant

Vincent J. Commisa, Asst. U. S. Atty., Newark, N. J. (David M. Satz, Jr., U. S. Atty., Newark, N. J., William W. Goodrich, Asst. General Counsel for Food and Drugs, Joanne S. Sisk, Paul M. Hyman, Attorneys, United States Department of Health, Education, and Welfare, Washington, D. C., on the brief), for appellee.

Before HASTIE and SMITH, Circuit Judges, and KIRKPATRICK, District Judge.

OPINION

KIRKPATRICK, District Judge.

This appeal is from a judgment of the District Court condemning as misbranded, within the meaning of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 334, a quantity of vitamin products. The misbranding charged by the Government was that the labeling of the products was not in compliance with Section 352(f) (1) of the Act in that it failed to bear "adequate directions for use." The appellant, Foods Plus, Inc., the manufacturer and owner of the seized articles, filed a claim for them in the District Court.

Having earlier in the proceeding allowed the Government to amend its libel by adding a prayer for an injunction, the Court, in addition to condemning the products, enjoined the claimant from any act which would result in the products under seizure, or any similar products, being introduced into interstate commerce if misbranded in the manner which the Court had found violative of the Act.

The trial judge found as a fact that the articles seized (which comprised various quantities of some 43 different formulas of vitamin, mineral and other dietary preparations) were drugs — a finding not now disputed.

The labeling in this case consisted of a catalog of the vitamin and mineral products offered for sale by the claimant, it having been stipulated that its catalogs were labels within the meaning of the Act.

Whether labeling contains "adequate directions for use" of an article necessarily depends upon what it is intended to be used for. In this case, although the catalogs were in a general way suggestive of therapeutic values for the products, they contained nothing whatever to indicate for what diseases or conditions the various preparations were supposed to be beneficial and, in consequence, nothing to show how they were to be used or administered. Since failure to include this information constituted the inadequacy of labeling charged, proof of the intended use of the preparations was a vital part of the Government's case. The Government undertook to show that the claimant intended its vitamin products to be used as medicaments for the prevention, mitigation or cure of various diseases in man, and the Court made a finding to that effect. Whether the evidence was sufficient to support that finding is the point upon which this case turns.

The evidence consisted mainly of transcripts of a series of radio broadcasts by

362 F.2d 926
one Carlton Fredericks whom the claimant described in its catalog as an "internationally prominent nutritionist." The broadcasts were commentaries covering the general subject of public health, principally in the field of nutrition, with heavy emphasis being placed upon the therapeutic value of vitamins and of food products fortified by vitamins, the central idea being that many of the ills of man, from simple malaise to serious diseases, can be beneficially treated by the use of vitamins and minerals as dietary supplements

Neither Foods Plus, Inc., nor the trade name of any of its products was mentioned in any of the Fredericks broadcasts. However, advertisements of Foods Plus vitamins were presented in commercials, some of which immediately succeeded the Fredericks programs. Whenever a listener responded to Fredericks' broadcast invitations to write to him for nutritional information, advice or literature, the claimant, which had Fredericks under...

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37 practice notes
  • Food for human consumption: Food labeling— Dietary supplements; effect on structure or function of body; types of statements, definition,
    • United States
    • Federal Register January 06, 2000
    • January 6, 2000
    ...Amendment violation. (See Wisconsin v. Mitchell, 508 U.S. at 489; United States v. Articles of Drug * * * B- Complex Cholinos Capsules, 362 F.2d 923, 927 (3d Cir. 1966) (no impingement on free speech for FDA to use statements made by a lecturer employed by a manufacturer as evidence of the ......
  • Zenith Radio Corp. v. Matsushita Elec. Ind. Co., Civ. A. No. 74-2451
    • United States
    • U.S. District Court — Eastern District of Pennsylvania
    • September 29, 1980
    ...the adopting party has not been shown to have knowledge of the contents of the material "adopted," is United States v. Article of Drug, 362 F.2d 923 (3d Cir. 1966). The evidence there consisted of transcripts of a series of radio broadcasts, admitted to establish the intended use of vitamin......
  • United States v. Regenerative Scis., LLC, No. 12–5254.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • February 4, 2014
    ...the Procedure does not in itself preclude injunctive relief. See United States v. Article of Drug Designated B–Complex Cholinos Capsules, 362 F.2d 923, 928 (3d Cir.1966) (“It is well [741 F.3d 1326]settled that the cessation of activities, either before or after suit is begun, does not in i......
  • US v. 22 Rectangular or Cylindrical Devices, Civ. No. 86-C-0486G.
    • United States
    • U.S. District Court — District of Utah
    • January 12, 1989
    ...standing alone, provide a defense to a statutory injunction. See e.g., United States v. An Article of Drug, B-Complex Cholinos Capsules, 362 F.2d 923, 928 (3d Cir.1966); United States v. Sene X Eleemosynary Corp., Inc., 479 F.Supp. 970, 981 (S.D.Fla. 1979). This is particularly true where, ......
  • Request a trial to view additional results
36 cases
  • Zenith Radio Corp. v. Matsushita Elec. Ind. Co., Civ. A. No. 74-2451
    • United States
    • U.S. District Court — Eastern District of Pennsylvania
    • September 29, 1980
    ...the adopting party has not been shown to have knowledge of the contents of the material "adopted," is United States v. Article of Drug, 362 F.2d 923 (3d Cir. 1966). The evidence there consisted of transcripts of a series of radio broadcasts, admitted to establish the intended use of vitamin......
  • United States v. Regenerative Scis., LLC, No. 12–5254.
    • United States
    • United States Courts of Appeals. United States Court of Appeals (District of Columbia)
    • February 4, 2014
    ...the Procedure does not in itself preclude injunctive relief. See United States v. Article of Drug Designated B–Complex Cholinos Capsules, 362 F.2d 923, 928 (3d Cir.1966) (“It is well [741 F.3d 1326]settled that the cessation of activities, either before or after suit is begun, does not in i......
  • US v. 22 Rectangular or Cylindrical Devices, Civ. No. 86-C-0486G.
    • United States
    • U.S. District Court — District of Utah
    • January 12, 1989
    ...standing alone, provide a defense to a statutory injunction. See e.g., United States v. An Article of Drug, B-Complex Cholinos Capsules, 362 F.2d 923, 928 (3d Cir.1966); United States v. Sene X Eleemosynary Corp., Inc., 479 F.Supp. 970, 981 (S.D.Fla. 1979). This is particularly true where, ......
  • United States v. Sene X Eleemosynary Corp., Inc., No. 79-2661-Civ-SMA.
    • United States
    • United States District Courts. 11th Circuit. United States District Courts. 11th Circuit. Southern District of Florida
    • October 29, 1979
    ...of a statutory injunction sought to protect the public health. United States v. An Article of Drug . . . B Complex Cholinos Capsules, 362 F.2d 923, 928 (3rd Cir. 1966); United States v. W. T. Grant, supra; Allee v. Medrano, 416 U.S. 802, 810-811, 94 S.Ct. 2191, 40 L.Ed.2d 566 (1974). This i......
  • Request a trial to view additional results

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